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NCT Number: NCT01516593

Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma

This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma.

Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.

Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.

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Key information

Conditions

HIV Burkitt Lymphoma Burkitt's Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oncologia Medica A - Centro di Riferimento Oncologico, Aviano (PN), Italy

Loading trial locations.

About this study

The activity of feasibility of the proposed program will be assessed in HIV+ patients with Burkitt lymphoma with the aim to improve tolerability, minimize source consuming and supporting treatment and redu ce late sequels. Available combinations in this setting are really source demanding and toxic combinations showing high rates of septic complication and a treatment-related mortality of near 20%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic diagnosis of Burkitt's lymphoma (WHO 2008)
  • HIV sero-positivity
  • Age ≥18 and ≤60 years
  • ECOG-PS ≤3

Exclusion criteria

  • CNS parenchymal involvement
  • Absolute neutrophil count <1.000 cells/μL and platelets count <75 × 109/L (Burkitt unrelated)
  • Creatinine >1,5N (Burkitt unrelated)
  • SGOT and/or SGTP >2,5N (Burkitt unrelated)
  • Bilirubin >2N (Burkitt unrelated)
  • Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance
  • Significant cardiac disease or acute myocardial infarction in the last 12 months
  • Severe active infection (except for HBV and/or HCV co-infection)

Treatment and study plan

Induction Phase

Drug
  • dd -2 to 1: Methylprednisolone
  • dd 0-1, Cyclophosphamide, associated on day 0 with Vincristine
  • dd 2, Rituximab
  • dd 7, Methotrexate
  • dd 14, Rituximab
  • dd 15, Etoposide
  • dd 21, Methotrexate
  • dd 29, Rituximab and Doxorubicin
  • dd 36, Rituximab and VCR

At the end of this induction phase, subsequent treatment will be performed according to the objective response:

  • pts in CR: consolidation phase followed by bulky site irradiation
  • pts in PR: consolidation phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation
  • pts with SD after induction or PD during or after induction: intensification phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation

Other names: Short-term intensive sequential chemoimmunotherapy

Consolidation Phase (on day +50)

Drug
  • dd 1-2: cytarabine twice a day
  • dd 3 and 11: rituximab
  • dd 11-13: leukapheresis for PBPC collection.

Other names: high-dose cytarabine; consolidation phase

Intensification phase

Drug
  • One or two courses of R-IVAC or R-ICE chemoimmunotherapy regimen, every three weeks as debulking.
  • CTX (dd 1) associated with rituximab on dd 3 and 10, followed by PBPC collection (dd 11-13);
  • AraC every 12 hours for four days (dd -5 to -2) supported by reinfusion of CD34+ cells (dd 0), rituximab infusion (dd -1 and +11) and second in-vivo purged PBPC collection (if needed).

Other names: unresponsive patients, refractory disease

BEAM conditioning

Drug

BCNU on dd 1; VP-16 every 12 hours on dd 2-5 and araC every 12 hours on dd 2-5; melphalan on dd 6, followed by the reinfusion of CD34+ cells

Other names: Conditioning regimen, autologous transplantation

Consolidation radiotherapy

Radiation

At the end of the whole program, patients will be evaluated for involved-field irradiation with 6-10 MeV photons and a dose of 36 Gy (2 Gy/d, five fractions a week). Three subgroups of patients will be considered for radiotherapy

Other names: bulky irradiation; residual lesion

Primary outcomes

  1. evaluation of activity of the induction phase in terms of complete remission rate

    Time frame: at the end of the induction phase of the investigational intensive chemotherapy, an expected average of 45 days

    Objective lymphoma response achieved after the induction phase of the experimental treatment.

Secondary outcomes

  1. Feasibility and tolerability of the investigational intensive chemotherapy in terms of grade ≥4 adverse events

    Time frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days

    Assessment of incidence of grade 4 AE during experimental treatment (induction, consolidation and intensification phases as well as conditioning and autologous stem cell transplantation (if indicated)

  2. Feasibility and tolerability of the consolidation phase followed by BEAM conditioning and autologous stem cell transplantation in terms of prevalence of grade ≥4 adverse events

    Time frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days

  3. Feasibility and tolerability of intensification phase in terms of prevalence of grade ≥4 adverse events

    Time frame: participants will be followed for the duration of the whole experimental program, an expected average of 100 days

    Participants who will not achieve a complete or partial response after induction and consolidation phases will be referred to intensification phase, which will be followed by BEAM + ASCT. These patients will be assess for tolerabbility and AE during these therapeutic phases.

  4. Activity of the whole investigational program in terms of complete remission rate

    Time frame: at the end of the whole program, an expected average of 100 days

    Participants will be assessed by conventional exams to define complete remission rate after the whole experiemntal program; that is after consolidation phase for patients who achieved complete remission after induction phase, after BEAM + ASCt for patients who achieved partial response after induction phase, and after intensification phase for patients who did not achieve an objective response after induction phase.

Sponsors and collaborators

Lead sponsor

Andres J. M. Ferreri

Other

Registry information

Official study title

Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma

Acronym: CARMEN

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Jan 25, 2012
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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